

#### [126] prorx-llc-723704-04072026 | issued 04/07/2026 | ProRx LLC | SUBJ: Compounding Pharmacy/Adulterated Drug Products
WARNING LETTER WL # 723704 April 7, 2026 Dear Mr. Fletcher: You registered your facility with the U.S. [B181] 1 on April 27, 2022, and most recently on February 20, 2026. From September 9, 2025, to September 19, 2025, an FDA investigator inspected your facility, ProRx LLC, located at 619 Jeffers Cir, Exton, PA 19341. During the inspection, the investigator noted that drug products you produced failed to meet the conditions of section 503B of the FDCA necessary for drugs produced by an outsourcing facility to qualify for exemptions from certain provisions of the FDCA. In addition, the investigator noted serious deficiencies in your practices for producing drug products intended or expected to be sterile, which put patients at risk. FDA issued a Form FDA 483 to your facility on September 19, 2025, and an amended Form FDA 483 on October 10, 2025. We reviewed your October 24, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence on February 13, 2026. FDA also acknowledges that, on October 15, 2025, your firm initiated a voluntary recall of Lot PRORX08062025-3 of Tirzepatide Injection 27mg/3mL, 3mL in multidose vials and various lots of Semaglutide Injection multidose vials in multiple strengths, within expiry, due to a lack of sterility assurance. [B176] A. [B168] [B106] [B221] [B182] [B174] [B184] In addition, for a drug product compounded using bulk drug substances to qualify for the exemptions under section 503B, the bulk drug substances that are used must appear on a list established by the Secretary identifying bulk drug substances for which there is a clinical need (“503B bulks list”), or the compounded drug must appear on the drug shortage list in effect under section 506E of the FDCA at the time of compounding, distribution, and dispensing (section 503B(a)(2)(A) of the FDCA [21 U.S.C. § 353b(a)(2)(A)]). In addition, for a compounded drug product to qualify for the exemptions under section 503B, the labeling of the drug must include certain information (section 503B(a)(10) of the FDCA [21 U.S.C. §353b(a)(10)]). Further, for a compounded drug product to qualify for the exemptions under section 503B, it must be compounded in an outsourcing facility that is in compliance with the registration and reporting requirements in section 503B(b), including the requirement to submit adverse event reports to FDA “in accordance with the content and format requirements established through guidance or regulation under section 310.305 of title 21, Code of Federal Regulations (or any successor regulations)” [B172] B. Failure to Meet the Conditions of Section 503B During the inspection, the FDA investigator noted that drug products produced by your facility failed to meet the conditions of section 503B. For example, the investigator noted: 1. Your facility compounded drug products using tirzepatide bulk drug substance. For example, on (b)(4) , your facility compounded (b)(4) vials of Tirzepatide 72MG/4ML injectable drug product and on (b)(4) , your facility compounded (b)(4) vials of Tirzepatide 45MG/2.5ML injectable drug product, using tirzepatide bulk drug substance on both dates. These drug products compounded using tirzepatide bulk drug substance are not eligible for the exemptions provided by section 503B because tirzepatide does not appear on the 503B bulks list and was not used to compound a drug that appears on FDA’s drug shortage list at the time of compounding, distribution, and dispensing (section 503B(a)(2)(A). 3 2. Some of your facility’s drug products, such as Nicotinamide Adenine Dinucleotide Injection 1200mg, Glutathione Injection 2000mg, and Tirzepatide Injection 45mg/2.5mL, did not include the following statement on the label: the statement “Not for Resale” (section 503B(a)(10)(A)(iii)(IX)). Additionally, some of your facility’s drug products, such as Nicotinamide Adenine Dinucleotide Injection 1200mg, did not contain the following on the label: the established name of the drug (section 503B(a)(10)(A)(iii)(II)). 3. [B218] 4 Specifically, your facility’s procedures for reporting adverse events are inadequate. For example, your documented procedures for reporting adverse events do not include an adequate definition of what constitutes a “serious” adverse event (21 CFR 310.305(b)) and do not require the firm to promptly investigate a serious, unexpected adverse event and submit a follow-up report within 15 calendar days of receipt of new information or as requested by FDA (21 CFR 310.305(c)(2)). [B283] Specific violations are described below. C. [B252] For example, the investigator noted: 1. You did not perform adequate product evaluation and take appropriate corrective action after microbial contamination was recovered within the ISO 5 production area. Instead, your firm approved and distributed drug products that were produced with colony-forming unit (CFU) recoveries found on ISO 5 operator gloves and settle plates. 2. An operator blocked first air by placing gloved hands and/or forearms directly over open tray of stoppers intended to be sterile during critical in-process operations within the ISO 5 production areas. 3. You did not disinfect materials during transfer from the ISO 7 cleanroom into the ISO 5 laminar airflow workstation (LAFW). Specifically, an operator removed the outer packaging of stoppers in the ISO 7 area and the inner bag was then transferred from the ISO 7 area into the ISO 5 LAFW without surface disinfection. The inner bag of stoppers could be held for up to (b)(4) within the ISO 7 area before being transferred into the ISO 5 LAFW. 4. An operator used non-sterilized scissor within the ISO 5 processing area. This scissor was used to cut open a bag of stoppers inside the ISO 5 LAFW during filling operation of drug product intended to be sterile. This scissor was routinely stored in the ISO 7 area and was only wiped with (b)(4) wipe prior to use. 5. You had production areas or equipment that are difficult to clean or contain porous, particle-generating, or visibly dirty (e.g., rusty) equipment or surfaces (e.g., shelving, floors, walls, doors, ceilings). Specifically, the floor of the ISO Class 7 buffer room equipped with an ISO 5 LAFW and Biological Safety Cabinet (BSC) showed significant visible sporadic discoloration, the cause of which remains unknown. The FDA investigator also noted CGMP violations at your facility, that caused your drug products to be adulterated within the meaning of section 501(a)(2)(B) of the FDCA. The violations include, for example: 1. [B215] 2. [B216] 3. [B183] 4. Your firm’s quality control unit failed to approve or reject all procedures or specifications impacting on the identity, strength, quality, and purity of the drug product (21 CFR 211.22(c)). 5. Your firm failed to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions (21 CFR 211.42(c)(10)(v)). [B178] [B169] [B180] [B173] [B177] [B151] [B140] [B179] 5 Under sections 505(a) and 301(d) of the FDCA [21 U.S.C. §§ 331(d)] a new drug may not be introduced into or delivered for introduction into interstate commerce unless an application approved by FDA under section 505 of the FDCA is in effect for the drug. [B105] [B220] [B217] [B170] [B167] D. Corrective Actions We have reviewed your facility’s October 24, 2025, response to the Form FDA 483 and acknowledge receipt of your subsequent correspondence on February 13, 2026. We also acknowledge on October 15, 2025, your firm initiated a voluntary recall of Lot PRORX08062025-3 of Tirzepatide Injection 27mg/3mL, 3mL in multidose vials and various lots of Semaglutide Injection multidose vials in multiple strengths, within expiry, due to a lack of sterility assurance. Regarding your October 24, 2025 response related to the insanitary conditions and CGMP violations, some of your corrective actions appear adequate; however, we cannot fully evaluate the adequacy of the following corrective actions described in your response because you did not include sufficient information or supporting documentation: 1. Regarding your disinfectant efficacy studies, your response indicated initiating a comprehensive cleaning validation and disinfectant efficacy study on October 17, 2025, covering all disinfectants currently in use. You contracted (b)(4) to conduct efficacy testing against in-house isolates and common cleanroom contaminants, including molds and bacterial strains recovered during environmental monitoring (EM). While you agreed to share the protocol results with FDA once complete, the current status and expected completion timeline remain unclear, leaving questions about whether your existing cleaning disinfectants can adequately maintain your ISO 5 LAFWs, BSCs, and cleanroom environments. 2. Regarding your floor discoloration of the ISO 7 cleanroom, your response indicated that a deviation investigation and corrective action and preventive action (CAPA) plan were initiated to address this issue. You determined the root cause to be the use of (b)(4) , which exceeded the (b)(4) tolerance threshold of your existing (b)(4) flooring. Your corrective action involves installing replacement flooring capable of withstanding your cleaning protocol, followed by third-party cleanroom certification. You have suspended all aseptic compounding pending certification completion. However, your response lacks critical documentation, including evidence of when flooring construction occurred, documentation verifying the new flooring's appropriateness for pharmaceutical cleanroom use, and a timeline for completing construction and resuming aseptic production. Some of your corrective actions appear deficient: 1. Regarding your failure to conduct adequate investigations, our comprehensive review of your firm’s multiple deviation reports and SOPs reveals significant deficiencies in documentation and execution procedures for out-of-specification (OOS) events and deviation investigations. The following examples illustrate some of these deficiencies: Your deviation reports (DEV-2025-05 and DEV-2025-06) provide only minimal information, such as the description of the deviation and the immediate action(s) taken. These reports lack critical details regarding the investigation into the root cause of the deviation. Your firm has not established clear criteria for determining when investigations should be initiated following the opening of a deviation. Specifically, SOP QA-190 Deviation Procedure section 2.e. states, “Upon accepting the Deviation Form QA determines if an investigation and/or CAPA is required, checks the appropriate box (Yes or No), assigns and records the investigation and CAPA number.” However, your revised SOPs (SOP QA-190, QA-080 Root Cause Investigation Procedure , and QA-180 Corrective and Preventative Action (CAPA) Procedure) do not provide any details on the criteria for determining when a deviation warrants a formal investigation and CAPA. This represents a critical gap in your quality management system. Your firm’s responses did not include any retroactive investigation or root cause analysis addressing the multiple microbial growth detected in personnel fingertip samples collected following production activities in the ISO 5 area. Nor did your firm perform any retroactive investigation or root cause analysis for the CFUs recovered from surface samples during (b)(4) EM of the ISO 5 areas. Your response did not address why investigations were not extended to other batches produced by operators when contamination was recovered on consecutive days during personnel monitoring of those same operators. Furthermore, a passing sterility test result does not indicate the absence of contamination within a batch, as microbial growth is not uniformly distributed throughout a batch. Your firm’s response regarding the recovery of 1 CFU of Trichoderma oriental from an air sample of the ISO 7 area during production of Tirzepatide 60mg/3mL on 01/16/25 was inadequate. While the 1 CFU recovered did not exceeded the ISO 7 acceptance limit, the nature of this microorganism necessitates further action. Since this organism is not part of the normal cleanroom flora and it was recovered during the capping process during the production of drug product intended to be sterile, your firm should have conducted an investigation and included this microbial recovery in the trending data. Furthermore, your SOPs (SOP QA-190, QA-080, and QA-180) are missing signatories (author, reviewer, QA approver) and an effective date, making it unclear whether these represent the final, official version of these SOPs. In fact, the majority of SOPs you provided in your response lack these critical signatories that are essential for Good Documentation Practices (GDP) to ensure accountability, authorization, and data integrity (ALCOA principles: attributable, legible, contemporaneously recorded, original or a true copy, and accurate). 2. Regarding your firm’s deficiency in monitoring environmental conditions, your SOP CSP-080 Viable and Nonviable Air Sampling states viable air sampling “is conducted continuously during the compounding of CSPs in the ISO 5 environment by compounding personnel”. Our review of your SOPs and batch record reveals a fundamental misunderstanding of the distinction between active and passive viable air monitoring methods. Specifically, the viable monitoring documented in your batch record pertains to passive viable air monitoring (settle plate). While settle plates can provide valuable information about environmental monitoring conditions, they do not fulfill regulatory requirements. Active viable air monitoring is required under CGMP regulations. Furthermore, the viable air monitoring specification outlined in your SOP CSP-080 appears to address active viable air monitoring, yet no specifications are provided for the passive viable air monitoring. Furthermore, your firm’s SOP CSP-090 Surface Sampling Procedure states, "Surface sampling must be performed in all ISO classified areas on a (b)(4) basis, or more frequently on a risk-based approach if trending excursions are identified." This is inadequate, as surface monitoring should be conducted at least (b)(4) during operations within the ISO 5 area. 3. Regarding your March 19, 2025, Dynamic Smoke Study, your response claimed the study demonstrated that first air to the stoppers was maintained and there was no contamination risk from your operator forearms during the stoppering process in your ISO 5 area. However, our review of your dynamic smoke study reveals several critical deficiencies that contradict these claims. The video footage shows operators extending their forearms and gloved hands directly over both the sterile stopper tray and open vial tray during stoppering operations in the ISO 5 hood, contradicting your assertion of no obstruction. Moreover, the stopper tray was empty during the smoke study, operators were simulating stopper pickup with tweezers and transfer over open vials rather than performing actual operations. Additionally, the smoke study reveals significant airflow concerns in both the ISO 5 LAFW and ISO 7 cleanroom. The air movement exhibits an (b)(4) trajectory toward the ceiling rather than the top-down movement and dilution of HEPA filtered air in the ISO 7 cleanroom. This (b)(4) pattern in the ISO 5 LAFW suggests that vials and stoppers may not be receiving adequate first air protection. Furthermore, the vial tray positioning creates a raised lip around the tray perimeter that may further impede proper airflow and compromise sterile protection of open vials. Visible turbulence is evident over the vial tray, further indicating compromised airflow. 4. Regarding your media fills, your firm’s response indicates that SOP PT-020 Personnel Aseptic Qualification has been revised to require each operator to complete (b)(4) successful media fill runs that simulate actual production conditions. The revised SOP incorporates "best- and worst-case scenarios" with varying unit quantities (ranging from minimum of (b)(4) to a maximum of (b)(4) ) and different fill volumes (1.2mL, 10.4mL and 30.4mL). However, your firm did not provide the media fill production batch record that would demonstrate how these requirements are implemented in your actual media fill procedures. Furthermore, while your response states all operators will be retrained and requalified on the revised SOP, no timeline was provided for completing this retraining and requalification. 5. Regarding your lack of change control, your firm’s response maintains that construction at your facility is occurring in an adjacent suite and poses no cross-contamination risk to the aseptic cleanroom. However, you did not provide any change control documentation, risk assessment, or other supporting evidence demonstrating how construction of a new facility within the same building does not pose a risk of cross-contamination and loss of environmental control. Such risks include particulate and microbial intrusion, personnel and material movement, and disruption of facility integrity. Additionally, your firm’s response states you are implementing a robust change control system. However, review of your revised change control documents (QA-241 Change Control Form , QA-240 Change Control Management Procedure , and related training logs) reveals inadequate instructions and insufficient detail for personnel to properly assess and execute the change control process. Key deficiencies include Attachment #1: Change Impact and Risk Assessment Checklist , which appears to be a required component of the QA-241 Change Control Form but is not referenced in SOP QA-240. Neither document provides criteria for evaluating the impact and risk associated with each item within the checklist. The checklist uses a simple Yes/No format without requiring justification or rationale for conclusions and the impact/risk assessment checklist appears to depend solely on the requester rather than involving a multidisciplinary team or subject matter experts. The procedure fails to specify QA's approval or rejection criteria and does not clarify whether decisions rely exclusively on checklist responses. There are no provisions for assessing change effectiveness or consequences post-implementation. 6. Regarding your visual inspection (VI) program, your firm’s response indicates that you are “engaging all operating personnel in a robust visual inspection competency and training program.” However, your visual inspection documents (QA-220 Acceptance Sampling Procedure , CSP-140 Visual Inspection Procedure , and PT-100 Visual Inspection Qualifications Procedure ) provided with your response contain significant deficiencies. For example, your visual inspection qualification exam uses only (b)(4) with a (b)(4) time limit, despite batch sizes that range from (b)(4) . The exam also employs a scoring system that lacks clear scientific justification for the assigned point values. Furthermore, your revised procedures eliminated the previous requirement for (b)(4) as part of your personnel qualification of operator conducting visual inspection. This requirement should be maintained as essential criteria for inspector qualification to ensure inspectors possess adequate visual acuity to identify defects. Additionally, your firm's SOP CSP-140 delegates defect categorization entirely to quality control (QC) personnel after inspection by your operations personnel. Your visual inspection procedures do not address the disposition of defective units identified by operators but not confirmed by QC personnel. It remains unclear whether such units would be included in batch release or rejected. Your firm’s defect classification system for minor, major and critical defects remain inadequate. Your firm did not provide scientific justification for classifying all particulates as major defects. A risk-based approach should evaluate multiple factors—including particle size, route of administration, and whether particulates are extrinsic or intrinsic—to determine the appropriate defect classification. Additionally, SOP CSP-140 classifies loose and missing crimps as minor defects despite their potential to compromise container closure integrity, permit microbial ingress, and threaten sterility assurance of your drug product intended to be sterile. We acknowledge that SOP QA-220 Acceptance Sampling Procedure establishes a framework for AQL statistical sampling and defines limits for minor, major, and critical defect classifications. However, your visual inspection competency and training program exhibits significant deficiencies, as discussed above. Given these deficiencies, it does not appear your firm can appropriately classify the different type and category of defects to adequately execute statistical sampling and classification. Your firm’s response also does not address batch yield specification as part of the VI program. Lastly, your response does not discuss the implementation of defect library or the training of VI inspectors and QC personnel using this library. [B175] See section 501 of the FDCA. [B154] [B152] [ See 21 CFR 210.1(b), 21 CFR 200.10(b).] Furthermore, regarding issues related to the conditions of section 503B of the FDCA, your corrective actions appear deficient: Although you submitted revised labels that adequately corrected the labeling deficiencies noted during the inspection, your revised label for Nicotinamide Adenine Dinucleotide no longer includes a list of active and inactive ingredients, identified by established name and the quantity or proportion of each ingredient, as required by section 503B(a)(10)(iii)(X). You did not address certain issues related to the conditions of section 503B of the FDCA, for example: 1. You did not address the issue of your firm compounding drugs using tirzepatide bulk drug substance. 2. You did not submit updated documented procedures for reporting adverse events. [B171] [B150] [B155] [B253] E. [B126] [B2] [B20] [B153] [B1] [B166] [B17] [B0] [B16] [B4] All correspondence should refer to the Warning Letter Number above (# 723704 ) and include a subject line that clearly identifies the submission as a Response to Warning Letter. [B6] Sincerely, /S/ Matthew J. Lash Acting Director Office of Compounding Quality and Compliance Office of Compliance Center for Drug Evaluation and Research cc: Gregory G. Gaiser, Senior Vice President ____________________ 1 See Pub. L. No. 113-54, § 102(a), 127 Stat. 587, 587-588 (2013). [B222] 3 These substances are also not within the scope of the policy applicable to certain bulk drug substances described in the final guidance titled, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act (Revision 1) . This guidance describes FDA’s interim regulatory policy for entities registered as outsourcing facilities under section 503B of the FDCA while the 503B bulks list is being developed. Specifically, the guidance sets out conditions under which FDA generally does not intend to take action against an outsourcing facility for compounding a drug product using a bulk drug substance that is not included on the 503B bulks list and that is not used to compound a drug that appears on the drug shortage list in effect under section 506E at the time of compounding, distribution, and dispensing. These conditions include that the drug product appears on “503BCategory 1 – Bulk Drug Substances Under Evaluation”, which includes substances that may be eligible for inclusion on the 503B bulks list, was nominated with adequate support for FDA to evaluate it, and has not been identified by FDA as a substance that appears to present significant safety risks pending further evaluation. For additional information, see the guidance at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM469122.pdf 4 For more information, see, FDA’s guidance, “Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act,” which can be found at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM434188.pdf. 5 The specific products made by your firm are drugs within the meaning of section 201(g) of the FDCA [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases and/or because they are intended to affect the structure or any function of the body. [B5] 6 Your compounded drug products are not exempted from the requirements of section 502(f)(1) of the FDCA by regulations issued by the FDA (see, e.g., 21 CFR 201.115). Content current as of: 05/12/2026 Regulated Product(s)

#### [127] new-life-pharma-llc-725661-04142026 | issued 04/14/2026 | New Life Pharma LLC | SUBJ: CGMP/Adulterated and Unapproved New Drug/Misbranded
WARNING LETTER New Life Pharma LLC MARCS-CMS 725661 — April 14, 2026 More Warning Letters Delivery Method: VIA EMAIL WITH READ RECEIPT Reference #: 320-26-65 Product: Drugs Recipient: Recipient Name Mr. Arthur Leong Recipient Title Director, QA New Life Pharma LLC 265 Livingston Street Northvale , NJ 07647-1901 United States Issuing Office: Center for Drug Evaluation and Research (CDER) United States Warning Letter 320-26-65 April 14, 2026 Dear Mr. Leong: The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, New Life Pharma LLC, 3012113519, at 265 Livingston Street, Northvale, from February 3 to February 13, 2026. Based on the inspection and a review of the evidence collected, we identified serious violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Your “Semaglutide Sterile Multi-Dose Vial” and “Tirzepatide Sterile Multi-Dose Vial” products are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). These products are misbranded drugs under section 502(o) of the FD&C Act, 21 U.S.C. 352(o) because you did not properly register you firm or list your drugs with FDA. In addition, your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B). Finally, during the inspection our FDA investigators documented that your firm delayed, denied, limited, and/or refused to permit an FDA inspection. Under section 501(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 21 U.S.C. 351(j), your drugs are adulterated in that they have been manufactured, processed, packed, or held in an establishment where the owner or operator has delayed, denied, limited, and/or refused to permit inspection. Introducing or delivering these drugs for introduction into interstate commerce violates sections 301(a), 301(d), 301(p), and 505(a) of the FD&C Act, 21 U.S.C. 331(a), 331(d), 331(p), and 355(a). Unapproved New Drug Violations Your “Semaglutide Sterile Multi-Dose Vial” and “Tirzepatide Sterile Multi-Dose Vial” are “drugs” under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body. Multiple factors demonstrate that these products are intended for use as drugs. For example, your registration as a drug manufacturer and listing of a semaglutide injectable drug in FDA’s drug registration and listing system provides evidence of your intent for these products to be used as drugs. (see 21 CFR 207.77(c)). Additional evidence that your products are intended to be used as drugs (see 21 CFR 201.128) includes their composition, consisting of semaglutide or tirzepatide active pharmaceutical ingredients, which are well-known as the active ingredients in drugs approved for indications related to weight loss and management of type 2 diabetes; their design as lyophilized powder in sterile glass multi-dose vials with rubber stoppers requiring reconstitution and parenteral injection; and the circumstances of their distribution, including shipment to weight loss clinics (“med spas”) and cosmetic surgery medical practices. In at least some instances, you shipped the drug with bacteriostatic water purchased online, providing the means to prepare an injectable drug for human administration. In addition, your labels for your products include a National Drug Code (NDC), as well as the term “Rx-only,” and “Sterile Multi-Dose Vial; Refrigerate after reconstitution,” indicating use as a prescription drug. Taken together, these factors collectively demonstrate your objective intent for these products to be used as drugs. Thus, your “Semaglutide Sterile Multi-Dose Vial” and “Tirzepatide Sterile Multi-Dose Vial” are “drugs” as defined in section 201(g)(1) of the FD&C Act. These products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for their labeled uses. [B107] 355(a). Based on a review of Agency records, no FDA-approved applications are in effect for your “Semaglutide Sterile Multi-Dose Vial” and “Tirzepatide Sterile Multi-Dose Vial.” Accordingly, these products are unapproved new drugs, and their introduction or delivery for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). Misbranded Drug Violations Failure to properly register and list i. Misrepresentation of manufacturing operations in your FDA firm registration Your firm failed to meet its registration and listing obligations under section 510 of the FD&C Act. Section 510 of the FD&C Act, 21 U.S.C. 360 requires, among other things, owners or operators of establishments engaged in the manufacture of drugs to register their establishments with FDA. Registrants must provide accurate information regarding the types of operations performed at each establishment (see 21 CFR 207.25(f)). A review of FDA’s drug registration database shows that New Life Pharma LLC registered as “Contract manufacturing for human over-the-counter drug products produced under a monograph.” However, our inspection revealed that your firm does not manufacture any OTC monograph drugs. Instead, your firm manufactures and distributes unapproved prescription drugs, including “Semaglutide Sterile Multi-Dose Vial” and “Tirzepatide Sterile Multi-Dose Vial.” Your firm's registration information misrepresents the type of drugs manufactured at your establishment and the nature of your manufacturing operations. ii. Failure to obtain a labeler code to properly list your drugs with FDA Your firm has also failed to fulfill its listing obligations under section 510(j) of the FD&C Act, 21 U.S.C. 360(j). New Life Pharma does not have any labeler codes assigned and has not listed any drugs with FDA, despite manufacturing drugs products for commercial distribution. Under 21 CFR 207.41, each registrant must list each drug that it manufactures for commercial distribution. Your firm manufactures various drugs, including finished drugs mentioned in this warning letter, but has not obtained a labeler code or listed any products under your labeler code. The failure to register in accordance with section 510 of the FD&C Act, 21 U.S.C. 360, and the failure to list your drugs in accordance with section 510(j), 21 U.S.C. 360(j), is a prohibited act under section 301(p) of the FD&C Act, 21 U.S.C. 331(p). In addition, your drugs are misbranded drugs under section 502(o) of the FD&C Act, 21 U.S.C. 352(o), because they were manufactured at an establishment not duly registered under section 510 and were not properly listed with FDA under section 510(j). Accordingly, “Semaglutide Sterile Multi-Dose Vial” and “Tirzepatide Sterile Multi-Dose Vial” products are misbranded drugs, and their distribution into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). CGMP Violations During our inspection, our investigators observed specific violations including, but not limited to, the below. We reviewed your March 6, 2026, response to our Form FDA 483 in detail. 1. [B183] Your firm manufactured multiple GLP-1 finished drug products such as sterile, multi-dose vials of semaglutide and tirzepatide, without appropriate procedures to prevent microbiological contamination of your drug products, purporting to be sterile. Your firm did not adequately validate the conditions under which you manufactured drug products intended to be sterile. For example, you did not perform aseptic processing simulations (media fills), airflow visualization (smoke) studies, cleaning validation, or establish a routine environmental monitoring program. In addition, you manufactured these drug products under purported ISO 8 conditions without adequate supporting microbiological and particulate data. This did not meet critical area (ISO 5) standards for aseptic operations. These deficiencies demonstrate that your firm lacked the fundamental controls necessary to ensure the sterility of your drug products. The requirements in 21 CFR 211.113(b) for sterile drugs are necessary to ensure sterility and safety of drugs administered to patients. Your failure to implement these requirements placed patients at serious risk of receiving non-sterile products, which could result in severe infections or other life-threatening complications. 2. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22). Your quality unit failed to ensure appropriate CGMP procedures and processes for the manufacturing of semaglutide and tirzepatide sterile multi-dose vials were established and followed. For example: Failure to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)). Failure to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality (21 CFR 211.84(d)(1) and 211.84(d)(2)). Failure to conduct appropriate laboratory testing to determine whether each batch of drug product purporting to be sterile and pyrogen-free conforms to such requirements (21 CFR 211.167(a)). Failure to establish and follow written procedures for cleaning and maintenance of equipment (211.67(b)). Failure to assure that the drug product bore an expiration date that was supported by appropriate stability testing (21 CFR 211.137(a)). These failures demonstrate that your quality control unit did not fulfill its fundamental responsibility to ensure that your manufacturing operations comply with CGMP requirements and that your drug products meet appropriate quality standards. See FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations to ensure drug safety at https://www.fda.gov/media/71023/download. Limiting the Inspection During the inspection, your firm denied FDA investigators access to two areas within the manufacturing suite labeled “Area Not In Use” stating the investigators did not have authority to enter these areas. You confirmed to the investigators that you were refusing access. This causes your drugs to be adulterated under section 501(j) of the FD&C Act, 21 U.S.C. 351(j). Under this provision, drugs are deemed adulterated if they have been manufactured, processed, packed, or held in an establishment where the owner, operator, or agent in charge has delayed, denied, limited, or refused an FDA inspection. FDA’s inspection authority under section 704(a) of the FD&C Act, 21 U.S.C. 374(a), extends to all areas of drug manufacturing facilities, including areas designated as “not in use.” Your designation of certain areas does not limit FDA’s statutory inspection authority. See FDA’s guidance document Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection at https://www.fda.gov/media/86328/download. Inadequate Response We reviewed your March 6, 2026, response to our Form FDA 483 in detail. Your response is inadequate because you fail to provide adequate evidence of corrective actions taken to bring your operations into compliance with CGMP or confidence that you can manufacture sterile drugs. Drug manufacturers labeling their product as sterile must recognize the serious public health implications of distributing a non-sterile product as it poses a significant health risk to patients. Drug Production Ceased On February 20, 2026, you committed to cease production of drug products at your facility. However, in later correspondence dated March 6, 2026, you indicated that production has been paused until appropriate media fill validation studies are completed, indicating that you intend to resume production after addressing the violations associated with sterile drug manufacturing. Considering all the drugs you manufactured are not approved by the agency and your systems for manufacturing sterile drugs are wholly lacking, you should not restart drug manufacturing at this facility. In response to this letter confirm that you will not manufacture drugs in the future. Drug Recall On February 19, 2026, FDA held a teleconference with you recommending you consider removing any batches of the GLP-1 drug products currently in distribution from the U.S. market. On February 25, 2026, you issued a voluntary recall of semaglutide and tirzepatide sterile multi-dose vials due to lack of assurance of sterility. The recalls were posted to the FDA’s Enforcement Report website at: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=218926 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=219020 https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=219021 Conclusion The violations cited in this letter are not intended to be an all-inclusive list of deviations that exist at your facility. [B2] This letter notifies you of our findings and provides you an opportunity to address them. [B279] [B282] [B84] [B281] [B280] Identify your response with FEI 3012113519 and ATTN: Maria Pavco. Sincerely, /S/ Jill P. Furman, JD Director Office of Compliance Center for Drug Evaluation and Research Content current as of: 04/21/2026 Regulated Product(s)

#### [128] harbin-jixianglong-biotech-co-ltd-723330-05012026 | issued 05/01/2026 | Harbin Jixianglong Biotech Co., Ltd. | SUBJ: CGMP/API/Adulterated and Misbranded Drugs
WARNING LETTER Harbin Jixianglong Biotech Co., Ltd. MARCS-CMS 723330 — May 01, 2026 More Warning Letters Delivery Method: Via Electronic Mail - Return Receipt Requested Reference #: 320-26-73 Product: Drugs Recipient: Recipient Name Mr. Guo Qing Leng Recipient Title President and General Manager Harbin Jixianglong Biotech Co., Ltd. North of Baoan Road, East of Changqing Street Hulan Qu Harbin Shi Heilongjiang Sheng , 150025 China Issuing Office: Center for Drug Evaluation and Research (CDER) United States Warning Letter 320-26-73 May 1, 2026 Dear Mr. Leng: The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Harbin Jixianglong Biotech Co., Ltd., FEI 3024038751, at North of Baoan Road, East of Changqing Street, Liminzhen Hulan District, Harbin, Heilongjiang, from November 3 to 7, 2025. This warning letter summarizes significant deviations from Current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (APIs). Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your APIs are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B). In addition, we reviewed your firm’s drug listing submissions in FDA’s electronic Drug Registration and Listing System (eDRLS) and found that you failed to provide drug listing information for your relabeled semaglutide as required under section 510(j) of the FD&C Act, 21 U.S.C. 360(j), and 21 CFR Part 207. Furthermore, your relabeled semaglutide was manufactured in an establishment not duly registered with FDA. Failure to provide listing information for a drug in accordance with 510(j) of the FD&C Act is prohibited under section 301(p) of the FD&C Act, 21 U.S.C. 331(p). Under section 502(o) of the FD&C Act, 21 U.S.C. 352(o), a drug is misbranded if, among other things, it was manufactured in an establishment not duly registered under section 510, or if it was not included in a list required by section 510(j). Under section 301(a) of the FD&C Act, 21 U.S.C. 331(a), it is a prohibited act to introduce or deliver for introduction into interstate commerce any drug that is misbranded. These violations are described in more detail below. Your semaglutide API is also misbranded under sections 502(a) and 502(b)(1) of the FD&C Act, 21 U.S.C. 352(a) and 352(b)(1). We reviewed your November 26, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence. During our inspection, our investigators observed specific deviations including, but not limited to, the following. 1. Failure of your quality unit to exercise its responsibility to ensure that APIs manufactured at your facility are in compliance with CGMP and failure to maintain complete traceability of APIs in commercial distribution. Your firm is a manufacturer of peptide APIs, including Glucagon-Like Peptide-1 (GLP-1) Receptor Agonist APIs. FDA investigators observed that your firm lacked adequate quality unit (QU) oversight for the receipt of materials, repackaging, relabeling, and related controls for APIs. Specifically, there is no quality unit approved procedure governing the repackaging and relabeling operations for APIs sourced from external manufacturers prior to distribution to the U.S. market. For example: On (b)(4) , your firm purchased semaglutide API (batch (b)(4) ) from (b)(4) , a supplier that was not on your approved supplier list. You repackaged and relabeled this batch without documentation and created a new labeled batch number, CP-030-20250711. Furthermore, on the label of the container you identified your firm, “Harbin Jixianglong Biotech Co. Ltd.,” as the manufacturer of API rather than (b)(4) , the firm from which you purchased the API. You also changed the manufacturing date of the API from (b)(4) to July 25, 2025, and the retest date from to (b)(4) to July 24, 2027, without appropriate supporting data. This GLP-1 API was distributed to the U.S. on August 23, 2025. On (b)(4) , your firm purchased semaglutide API (batch (b)(4) ) from (b)(4) , another supplier that was not on your approved supplier list at time of purchase and release. You repackaged and relabeled this batch without documentation and created a new labeled batch number, CP-030-20250911. You changed the manufacturing date of the API from (b)(4) to September 25, 2025, and the retest date from (b)(4) to September 24, 2027. This GLP-1 API was distributed to the U.S. on October 3, 2025. We note that on September 5, 2025, FDA implemented the Green List of Import Alert 66-80 to help address GLP-1 API drugs offered for import into the United States that appear to be adulterated or misbranded. As part of this Import Alert, GLP-1 API drugs from facilities not on the Green List would be subject to detention without physical examination upon import into the United States. Your firm was added to the Green List on September 5, 2025, based upon previously provided quality information. However, your firm purchased GLP-1 API (semaglutide) from (b)(4) , a facility that is not on the Green List of IA 66-80. You then labeled the GLP-1 API as manufactured by your firm and shipped this batch to the United States, even though it was not manufactured by a facility on the green list. FDA is concerned that identifying your firm and not the actual manufacturers may have been an attempt to circumvent safeguards associated with IA 66-80 and may pose a risk to consumers of receiving substandard GLP-1 APIs. On February 10, 2026, FDA held a teleconference with you recommending you consider removing the two relabeled batches of semaglutide API drugs currently in distribution from the U.S. market. At the teleconference meeting, you agreed to voluntarily recall the two batches of semaglutide API drugs in current distribution in the United States. We acknowledge that on February 19, 2026, you initiated a voluntary recall of the two semaglutide API batches distributed in the United States. Additionally, during the inspection, our investigators discussed with your firm your decision to release and distribute at least (b)(4) batches of tirzepatide API to the U.S. market prior to the completion of stability studies to support the (b)(4) retest date. Your firm did not have an adequate written scientific justification to support the tentative expiration date applied to these lots before distribution. In your response, you state that due to high demand of semaglutide API in the U.S., you “occasionally purchased the product externally for resale.” You acknowledge lacking appropriate procedures for the release of externally purchased products and lacking batch records for the repackaging and labeling operations. Your response is inadequate. Although you commit to prohibiting the sale of externally procured products moving forward, you failed to address actions to be taken on the two distributed semaglutide API batches in the U.S market. In response to this letter, provide: A risk assessment of all APIs you repackaged that are missing any required manufacturing documentation for release and distribution., notify your customers and determine if market actions, such as recall, is necessary. A summary of your systemic corrective action and preventive action (CAPA) plan to remediate the supplier qualification program and prevent use of unsuitable material suppliers. A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to: o a determination of whether procedures used by your firm are robust and appropriate o provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices o a complete and final review of each lot and its related information before the QU disposition decision o oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products Your stability report and data to support the claimed retest date for all of your APIs intended for U.S. market. 2. Failure to demonstrate that your manufacturing process can reproducibly manufacture an API meeting its predetermined quality attributes and failure to adequately validate written procedures for the cleaning and maintenance of equipment. Process Validation You failed to appropriately validate your processes prior to release and distribution of your API. Specifically, you manufactured and distributed two batches of semaglutide API to the U.S. market despite having conducted no process validation. Without adequate process validation, your firm lacks basic assurance that you can reproducibly deliver products that meet specifications. See FDA’s guidance document for general principles and approaches that FDA considers appropriate elements of process validation at https://www.fda.gov/media/71021/download In your response, you acknowledge that you have not initiated process validation for semaglutide API that you repackage and relabel. You compared the critical process parameters with the planned process validation lots and concluded that releasing these products without process validation was low risk. Your response is inadequate. Your risk assessment lacks sound scientific testing data to conclude low impact of using non-validated processes on APIs already distributed to the United States. Additionally, you failed to provide a complete process validation protocol for review. Your CAPAs lacked metrics for effectiveness of bringing your operations into compliance with CGMP. Cleaning Validation You lacked adequate cleaning validation studies that demonstrate your cleaning procedures for your manufacturing equipment are effective. For example, your cleaning procedure requires calculation of a maximum allowed carry over limit based on API toxicity. However, you did not establish a maximum allowed carryover limit in your cleaning validation study for the equipment used to manufacture peptide APIs, including semaglutide and tirzepatide. Furthermore, your cleaning validation study did not provide justification for the swab sampling locations, nor did it contain results from the swab sample testing as required by the same cleaning procedure. Inadequately cleaned and maintained manufacturing equipment can lead to potential cross-contamination that could compromise your API quality and safety. In your response you commit to drafting and executing a new cleaning validation protocol during your next production campaign in the original API workshop to include chemical residue testing on both direct and indirect product surfaces. Your response is inadequate because you did not provide a systemic CAPA for the deficiencies related to the misalignment between your cleaning procedure requirements and your cleaning validation study. In response to this letter, provide: Your process validation protocols and reports for all APIs shipped to or intended for the U.S. market. An assessment of each API process to ensure that there is a data-driven and scientifically sound program that identifies and controls all sources of variability, such that your production processes, and will consistently meet appropriate specifications and manufacturing standards. This includes, but is not limited to, evaluating suitability of equipment for its intended use, sufficiency of detectability in your monitoring and testing systems, quality of input materials, and reliability of each manufacturing process step and control. A comprehensive, independent retrospective assessment of your cleaning effectiveness to evaluate the scope of cross-contamination hazards. Include the identity of residues, other manufacturing equipment that may have been improperly cleaned, and an assessment whether cross-contaminated drugs may have been released for distribution. The assessment should identify any inadequacies of cleaning procedures and practices and encompass each piece of manufacturing equipment used to manufacture more than one product. 3. Failure to ensure that all specifications and test procedures are scientifically sound and appropriate to ensure that your APIs conform to established standards of quality and purity. You failed to establish that your analytical test methods are appropriately validated and suitable for use in API release testing. For example, in 2024 your firm shipped (b)(4) lots of tirzepatide API (about (b)(4) total weight) to the U.S. market without completing analytical method validation for assay and related substances by high-performance liquid chromatography, high molecular weight aggregates by size-exclusion chromatography, and amino acid ratio by high-performance liquid chromatography. Furthermore, in 2025, your firm shipped (b)(4) lots of tirzepatide API drugs (about (b)(4) total weight) without completing method verification for the bacterial endotoxin test. FDA is also concerned that your analytical method validation for tirzepatide API, specifically for related substance test (R-VTP-TP-11-009-024), is not adequate. The test method validation data you provided indicates poor resolution, overlapping peaks, and absence of structural identification for (b)(4) specified impurities. lack of comparative approach using multiple, orthogonal, high-resolution analytical methods for peptide-related impurity characterization. Your microbial limit enumeration test (R-VTP-TP-04-001-2025) validation data includes inconsistencies. For example, your test data for Pseudomonas aeruginosa are shown twice, and data for Bacillus subtilis is missing. For FDA’s current thinking regarding analytical test method validation and impurity characterization in synthetic peptides, see Analytical Procedures and Methods Validation for Drugs and Biologics at https://www.fda.gov/media/87801/download and ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin at https://www.fda.gov/media/107622/download In your response, you acknowledge that your semaglutide and tirzepatide API drugs are in the development stage and full validation of all analytical methods has yet to be completed. You also acknowledge deficiencies in your product release procedure and failure of your quality system processes to identify and correct these non-compliant practices in a timely manner. Your response is inadequate. Although you intend to implement a new procedure requiring your certificates of analysis to contain a statement of “Only for R&D use purpose” for “developmental drug products,” you did not mention any stipulations on the acceptable quantity to be released for R&D use. Based on your invoice and shipping documents, the quantity of API drugs (as much as (b)(4) ) shipped into the U.S. is inconsistent with quantities typically used for research and development purposes. In response to this letter, provide: A comprehensive assessment of your laboratory practices, procedures, methods, equipment, and documentation. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system. Your analytical validation protocols and reports for the release testing of all APIs shipped to or intended for the U.S. market. Appropriate microbiological batch release specifications (i.e., total counts, identification of bioburden to detect objectionable microbes) for each of your GLP-1 APIs. A detailed risk assessment addressing the hazards posed by distributing APIs with potentially objectionable microbial contamination. Specify actions you will take in response to the risk assessment, such as customer notifications and product recalls. A summary of results from testing retain samples of all API drugs distributed to the U.S market and within expiry. You should test all appropriate quality attributes including, but not limited to, identity and strength of active ingredients and microbiological quality (total counts and identification of bioburden to detect any objectionable microbes) of each lot. If testing yields an out-of-specification result, indicate the corrective actions you will take, including notifying customers and initiating recalls. 4. Failure to ensure that water used in the (b)(4) manufacturing steps of a non-sterile API intended for a sterile drug product is monitored and controlled for total microbial counts, objectionable organisms, and endotoxins. You manufacture GLP-1 APIs that were imported into the United States. These GLP-1 APIs are intended for use in sterile injectable drug products. Your firm failed to ensure that the (b)(4) water you used in the (b)(4) manufacturing steps of your APIs was suitable for its intended use. For example, your non-sterile semaglutide and tirzepatide API are intended for sterile injectable drug products, and your (b)(4) water system has not been evaluated for the absence of objectionable microorganisms. There is no indication that your (b)(4) water was tested for endotoxin during manufacturing processing. Furthermore, you failed to conduct sampling and microbial testing of the (b)(4) water you manually transported and stored for use in the (b)(4) manufacturing process of your APIs. (b)(4) water must be suitable for its intended use and routinely tested to ensure ongoing conformance with appropriate chemical and microbiological attributes. Routine and representative monitoring of microbial counts and identification of contamination in the system and at the point of use are integral to maintaining a state of control and the suitability of water used in manufacturing operations. In your response, you acknowledge your failure to perform a risk assessment of objectionable microorganisms and your resulting failure to evaluate the requirements for controlling objectionable microorganisms in your (b)(4) water system. You commit to establishing a microbial identification strategy and to adding E. coli testing for both the (b)(4) water system monitoring and to the API specification. Your response is inadequate. You did not include monitoring of additional objectional organisms as required by the United States Pharmacopeia (USP) monograph for (b)(4) water. In response to this letter, provide: Your commitment to routinely monitor and control endotoxins in your (b)(4) water to ensure its suitability for API intended for sterile drug products. Include alert/action limits, test methods, water analysis frequency, and diagrams of the water system, and location of all sampling points. The identification and assessment of all other aspects of the manufacturing process (e.g., input materials, holding times, equipment quality) that can contribute endotoxin to your APIs that may be used in parenteral manufacturing. A procedure for your water system monitoring that specifies routine microbial testing of water to ensure its acceptability for use in each lot of API produced by your firm. The current action/alert limits for total counts and objectionable organisms used for your (b)(4) water system. Ensure that the total count limits for your (b)(4) water are appropriately stringent in view of the intended use of each of the products produced by your firm. A procedure governing your program for ongoing control, maintenance, and monitoring that ensures the remediated system consistently produces water that meets (b)(4) Water USP monograph specifications, USP monograph tests for specified microorganisms, and appropriate microbial limits. Water analysis test results for a period of six months, obtained after implementation of additional testing including, but not limited to, sampling procedures and results for total microbial counts, objectionable organisms, and endotoxins. Drug Listing Violations Section 510(j) of the FD&C Act and 21 CFR Part 207 set forth the requirements for the listing of drugs. Under section 510(j)(1) of the FD&C Act and 21 CFR 207.41(a), a registrant must list each drug that it manufactures, repacks, relabels, or salvages for commercial distribution. Upon review of your firm’s batch records, it was found that you relabeled semaglutide purchased from (b)(4) and (b)(4) . You failed to list these relabeled drugs. Additionally, (b)(4) and (b)(4) are not referenced in any of Harbin’s drug listings for semaglutide as establishments where manufacturing is performed as required by 21 CFR 207.49(a)(12). Failure to provide listing information for a drug in accordance with 510(j) of the FD&C Act is prohibited under section 301(p) of the FD&C Act. Further, you relabeled semaglutide that you purchased from (b)(4) , a firm whose establishment registration is expired and that has not listed any drugs. 21 CFR 207.29 requires annual review and update of registration information for an establishment involved in the manufacture of drugs. Under section 502(o) of the FD&C Act, a drug is misbranded if, among other things, it was manufactured in an establishment not duly registered under section 510, or if it was not included in a list required by section 510(j). Under section 301(a), it is a prohibited act to introduce or deliver for introduction into interstate commerce any drug that is misbranded. Complete, accurate, and up-to-date establishment registration and drug listing information is essential to promote and protect patient safety. FDA relies on establishment registration and drug listing information for several key programs, including drug establishment inspections, supply chain security, and post-market surveillance. Establishment registration and drug listing information is also widely used outside FDA for purposes such as electronic prescribing and electronic health records, insurance reimbursement, and patient education. It is your responsibility to ensure that all drugs manufactured at your establishment comply with all establishment registration and drug listing requirements under section 510 of the FD&C Act, 21 U.S.C. 360, 21 CFR Part 207, and all other applicable FDA regulations. Registration and listing information and instructions on how to properly register an establishment or submit drug listings can be found at Electronic Drug Registration and Listing Instructions . Misbranded Drugs The semaglutide API labels for batch CP-030-20250711 and CP-030-20250911 bear the statement “Manufacturer: Harbin Jixianglong Biotech Co., Ltd.” This statement is misleading because it indicates that the manufacturer of the API in those batches is Harbin Jixianglong Biotech Co., Ltd. instead of (b)(4) . and (b)(4) . Therefore, the semaglutide APIs for batch CP-030-20250711 and CP-030-20250911 are misbranded under section 502(a) of the FD&C Act in that the labeling is false or misleading. In addition, section 502(b)(1) of the FD&C Act requires a drug to contain the name and place of business of the manufacturer, packer, or distributor of the drug. The labels of Harbin’s API products referenced above are misbranded under section 502(b)(1) because they misidentify Harbin, which is a distributor or packer, as the manufacturer. As evidenced by Harbin’s November 5, 2025 declarations, (b)(4) . and (b)(4) . are the manufacturers of the semaglutide API in batches CP-030-20250711 and CP-030-20250911, not Harbin Jixianglong Biotech Co., Ltd. Additional API CGMP Guidance FDA considers the expectations outlined in ICH Q7 when determining whether APIs are manufactured in conformance with CGMP. See FDA’s guidance document Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients for guidance regarding CGMP for the manufacture of API at https://www.fda.gov/media/71518/download CGMP Consultant Recommended Based upon the nature of the deviations identified at your firm, we strongly recommend engaging a consultant qualified to evaluate your operations to assist your firm in meeting CGMP requirements. We also recommend that the qualified consultant perform a comprehensive audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with FDA. Your use of a consultant does not relieve your firm’s obligations to comply with CGMP. [B245] Conclusion The deviations cited in this letter are not intended to be an all-inclusive list of deviations that exist at your facility. You are responsible for investigating and determining the causes of any deviations and for preventing their recurrence or the occurrence of other deviations. On February 27, 2026, your firm was placed on Import Alert 66-40 Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs and removed from the Green List of Import Alert 66-80 Detention Without Physical Examination of Glucagon-Like Peptide-1 (GLP-1) Receptor Agonist Bulk Drug Substances . This letter notifies you of our findings and provides you with an opportunity to address them. [B279] [B282] [B84] [B281] [B280] Identify your response with FEI 3024038751 and ATTN: Joan Johnson. Sincerely, /S/ Jill P. Furman, JD Director Office of Compliance Center for Drug Evaluation and Research Content current as of: 05/19/2026 Regulated Product(s)

#### [129] altru-telehealth-llc-dba-altru-telehealth-728274-06082026 | issued 06/08/2026 | Altru Telehealth, LLC dba Altru Telehealth | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER Reference number: MARCS-CMS 728274 To Altru Telehealth: [B46] [B42] [B26] [B56] [B20] [B1] FDA Review Violations were identified and documented during a review of Altru Telehealth’s website, https://altrutelehealth.com, FDA Establishment Identifier (FEI) 3044020130, in March 2026. [B71] [B72] [B49] [B41] [B28] [B73] [B60] [B61] More specifically, 1. [B74] “Compounded semaglutide combines the FDA approved active ingredient semaglutide with a body safe vitamin such as B12.” “Compounded semaglutide & tirzepatide offers the same results but at a fraction of the cost of brand names such as Ozempic, Mounjaro & Wegovy.” “Semaglutide & Tirzepatide is the active ingredient used in FDA-Approved weekly injection Wegovy® and Mounjaro….“ Compounded drug products are not FDA-approved. [B85] 2. Your website claims ”[a]n FDA approved, regulated & sterile compounding pharmacy mixes the formula based on the medical providers [sic] prescription” and “[o]ur compounding pharmacies are all FDA approved....” [B113] [B211] 2 Therefore, representing a compounding pharmacy or outsourcing facility as “FDA-approved” or “FDA-licensed” is false and misleading, as these terms imply a formal authorization that FDA does not grant to such entities or their compounded products. [B75] [B62] [B59] [B67] [B50] [B3] [B65] [B29] [B58] Identify your written response with reference number MARCS-CMS 728274 and Response to Warning Letter in the subject line of the email. [B27] Such steps may include the following: 1. [B53] 2. [B51] [B66] [B0] [B25] [B63] [B64] [B57] [B54] Sincerely, /S/ Matthew J. [B55] Food and Drug Administration ______________________ 1 The semaglutide and tirzepatide products offered on your website are drugs within the meaning of section 201(g) of the FD&C Act [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases and/or because they are intended to affect the structure or any function of the body. [B52] 2 While an entity may elect to register with FDA as an outsourcing facility under section 503B of the FD&C Act [21 U.S.C. § 353b], this registration does not constitute FDA approval or licensure of the facility or its compounded drug products. [B115] [B114] Content current as of: 06/16/2026 Regulated Product(s)

#### [130] amie-health-inc-dba-amie-728276-06082026 | issued 06/08/2026 | Amie Health, Inc. dba Amie | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER Reference number: MARCS-CMS 728276 To Amie: [B46] [B42] [B26] [B56] [B20] [B1] FDA Review Violations were identified and documented during a review of Amie Health, Inc.’s website, https://tryamie.com, FDA Establishment Identifier (FEI) 3044000672, in March 2026. [B71] [B72] [B49] [B41] [B28] [B73] [B60] [B61] More specifically, 1. The compounded semaglutide and tirzepatide products displayed on your website identify “amie” on the pictured label, suggesting Amie is the compounder of those drugs when in fact it is not. 2 2. [B74] “Ozempic, Mounjaro, and Wegovy contain the same active ingredients as our compounded versions (semaglutide and tirzepatide).” “All our treatments use FDA-approved active ingredients….” Compounded drug products are not FDA-approved. [B85] [B75] [B62] [B59] [B67] [B50] [B3] [B65] [B29] [B58] Identify your written response with reference number MARCS-CMS 728276 and Response to Warning Letter in the subject line of the email. [B27] Such steps may include the following: 1. [B53] 2. [B51] [B66] [B0] [B25] [B63] [B64] [B57] [B54] Sincerely, /S/ Matthew J. [B55] Food and Drug Administration ________________ 1 The semaglutide and tirzepatide products offered on your website are drugs within the meaning of section 201(g) of the FD&C Act [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases and/or because they are intended to affect the structure or any function of the body. [B52] [B76] [B80] [B79] However, see 45 Fed. Reg. 25760, 25765 (Apr. [B78] [B77] Content current as of: 06/16/2026 Regulated Product(s)

#### [131] clover-meds-llc-dba-clover-meds-728234-06082026 | issued 06/08/2026 | Clover Meds LLC dba Clover Meds | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER Reference number: MARCS-CMS 728234 To Clover Meds: [B46] [B42] [B26] [B56] [B20] [B1] FDA Review Violations were identified and documented during a review of Clover Meds’ website, https://clovermeds.com, FDA Establishment Identifier (FEI) 3044175705, in March 2026. [B71] [B72] [B49] [B41] [B28] [B73] [B60] [B61] More specifically, 1. The compounded semaglutide and tirzepatide products displayed on your website identify “Clover Meds” on the pictured label, suggesting Clover Meds is the compounder of those drugs when in fact it is not. 2 2. Your website claims that the compounded drug products it offers are sourced from “FDA-licensed Facilities.” [B113] [B211] [B129] [B75] [B62] [B59] [B67] [B50] [B3] [B65] [B29] [B58] Identify your written response with reference number MARCS-CMS 728234 and Response to Warning Letter in the subject line of the email. [B27] Such steps may include the following: 1. [B53] 2. [B51] [B66] [B0] [B25] [B63] [B64] [B57] [B54] Sincerely, /S/ Matthew J. [B55] [B233] [B52] [B76] [B80] [B79] However, see 45 Fed. Reg. 25760, 25765 (Apr. [B78] [B77] [B130] [B115] [B114] Content current as of: 06/16/2026 Regulated Product(s)

#### [132] dh-medical-services-728238-06082026 | issued 06/08/2026 | D&H Medical Services | SUBJ: False & Misleading Claims/Misbranded (Telehealth)
WARNING LETTER Reference number: MARCS-CMS 728238 To D&H Medical Services: [B46] [B42] [B26] [B56] [B20] [B1] FDA Review Violations were identified and documented during a review of D&H Medical Services’ website, https://www.dhmedicalcenter.com, FDA Establishment Identifier (FEI) 3044174854, in March 2026. [B71] [B72] [B49] [B41] [B28] [B73] [B60] [B61] More specifically, 1. [B74] “Same ingredient as Ozempic®” “Same ingredient as Rybelsus®” “Same ingredient as Mounjaro®” Compounded drug products are not FDA-approved. [B85] [B75] [B62] [B59] [B67] [B50] [B3] [B65] [B29] [B58] Identify your written response with reference number MARCS-CMS 728238 and Response to Warning Letter in the subject line of the email. [B27] Such steps may include the following: 1. [B53] 2. [B51] [B66] [B0] [B25] [B63] [B64] [B57] [B54] Sincerely, /S/ Matthew J. [B55] Food and Drug Administration ________________________________ 1 The semaglutide and tirzepatide products offered on your website are drugs within the meaning of section 201(g) of the FD&C Act [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases and/or because they are intended to affect the structure or any function of the body. [B52] Content current as of: 06/16/2026 Regulated Product(s)